A Comparison of High-flow Nasal Oxygen and Conventional Nasal Cannula in Monitored Anesthesia Care for Endoscopic Submucosal Dissection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-30

Study Completion Date

2025-10-18

Brief Summary

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Sedation for endoscopic submucosal dissection places patients at risk of desaturation, and high-flow nasal oxygen may reduce the risk. The aim of this study is to evaluate the role of high-flow nasal oxygen during endoscopic submucosal dissection. We will compare the incidence of hypoxemia (defined as SpO2 lower than 90%) of conventional nasal oxygen cannula group and that of high-flow humidified oxygen-delivery system group during the procedure.

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Detailed Description

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Conditions

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Patients Undergoing Endoscopic Submucosal Dissection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Arm 1: conventional nasal cannula group Arm 2: high-flow humidified oxygen-delivery system (OptiFlow THRIVE) group

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Patients will be randomly allocated to 2 groups using computer-generated randomization method. Neither participants nor physicians will be blinded to the groups because of organizational reasons.

Study Groups

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conventional oxygenation (nasal cannula) arm

conventional oxygenation arm will receive oxygen at 2L/min via nasal cannula

Group Type EXPERIMENTAL

conventional oxygenation (nasal cannula)

Intervention Type DEVICE

conventional oxygenation arm will receive oxygen at 2 L/min via nasal cannula, while Optiflow THRIVE arm will receive oxygen at 50 L/min via Optiflow THRIVE during the procedure.

high-flow humidified oxygen-delivery system (OptiFlow THRIVE) arm

Optiflow THRIVE arm will receive oxygen at 50 L/min via Optiflow THRIVE

Group Type EXPERIMENTAL

high-flow humidified oxygen-delivery system (OptiFlow THRIVE)

Intervention Type DEVICE

conventional oxygenation arm will receive oxygen at 2 L/min via nasal cannula, while Optiflow THRIVE arm will receive oxygen at 50 L/min via Optiflow THRIVE during the procedure.

Interventions

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conventional oxygenation (nasal cannula)

conventional oxygenation arm will receive oxygen at 2 L/min via nasal cannula, while Optiflow THRIVE arm will receive oxygen at 50 L/min via Optiflow THRIVE during the procedure.

Intervention Type DEVICE

high-flow humidified oxygen-delivery system (OptiFlow THRIVE)

conventional oxygenation arm will receive oxygen at 2 L/min via nasal cannula, while Optiflow THRIVE arm will receive oxygen at 50 L/min via Optiflow THRIVE during the procedure.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients who will undergo endoscopic sumucosal dissection under remimazolam-based sedation

Exclusion Criteria

* dementia or cognitive dysfunction
* altered mental status
* intubated patients or tracheostomy
* pregnancy
* recent history of nasal bleeding
* contraindication for positive pressure ventilation
* patients under oxygen therapy
* illiteracy or foreigner

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No